MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. VARIZED FEMORAL STEM EXCEPTION RIGHT SIZE 6; HIP, PROTHESIS

Catalog Number PV126Y06

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).List of associated devices: alu femoral head d28/+3.5/5 42/12-14, reference p0209l28, batch 0000399442; avantage reload cup ti ha s54, reference p0460p54, batch 0000349027; avantage inlay s54 / 28, reference p0561054, batch 0000374935.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that the patient fell and broke his femur around the implant (periprostetic fracture) on the (b)(6) 2019.On the (b)(6) 2019, the stem was revised in another center ((b)(6)) and replaced by a locked revision stem.The cup was not revised.On the (b)(6) 2019, the surgeon saw the patient again.The patient is very satisfied since the revision, walk and go his daily activities normally and without pain.He says that there was no relation with the implant, instrumentation, or procedure.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.Device history records: the device manufacturing quality record indicate that the released product met all requirements to perform as intended.Complaint history : a complaint extract was done regarding revision due to periprostetic fracture: 1 complaint (1 product), this one included, has been recorded on exception varized stem right size 6, reference pv126y06, from january 01, 2017 to february 10, 2021.1 complaint (1 product), this one included, has been recorded on exception varized stem right size 6, reference pv126y06, batch 0000316555.Device analysis : the product analysis can't be performed as the product was not returned.Other information review: the instruction for use has been reviewed and it is stated that excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation and/or wear.It is also stated that the patient must be warned that the device does not replace normal healthy bone, and that the implant can break or be damaged as a result of excessive load bearing or trauma.Conclusion: according to available data, the most probable root cause of the event could be the patient fall that led to the periprostetic fracture and the device revision.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

On the (b)(6) 2019, the patient fell and broke his femur around the implant (periprostetic fracture).On the (b)(6) 2019, the stem was revised in another center (b)(6) and replaced by a locked revision stem.The cup was not revised.On the (b)(6) 2019, the surgeon saw the patient again.The patient is very satisfied since the revision, walk and go his daily activities normally and without pain.He says that there was no relation with the implant, instrumentation, or procedure.

• Brand Name: VARIZED FEMORAL STEM EXCEPTION RIGHT SIZE 6
• Type of Device: HIP, PROTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10974251
• MDR Text Key: 220414341
• Report Number: 3006946279-2020-00233
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: PV126Y06
• Device Lot Number: 0000316555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 75